Introduction: Understanding E&L Testing FAQs for Safer Products
In the pharmaceutical and medical device world, ensuring patient safety is one of the top priorities. That’s why so many professionals search for answers around E&L Testing FAQs. E&L stands for Extractables and Leachables—chemicals that may move from packaging or device materials into a drug product. Detecting these substances is essential, especially for injectables, inhalation drugs, and implanted devices.
ResolveMass Laboratories has been at the forefront of E&L testing, offering trusted, science-backed services that meet all regulatory and safety standards. In this blog, we’ll walk you through the most common questions and answers about E&L testing. Whether you’re a developer, manufacturer, or quality officer, this guide will make complex terms easy to understand.
What is E&L Testing and Why Does It Matter?
Extractables and leachables are substances that can be released from packaging, containers, or delivery systems into a drug or medical product. Extractables are identified under intense lab conditions, simulating worst-case scenarios. Leachables, however, are detected during normal storage or usage and may enter the final product over time.
Understanding the role of E&L testing helps you avoid health risks, ensure compliance, and improve product quality. At ResolveMass, we offer tailored solutions that adapt to your product’s materials and contact types.
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Why is E&L Testing Required?
Health authorities like the FDA, EMA, and USP require E&L testing to protect patients and ensure the stability of drug products. When materials release unsafe chemicals, they can affect the drug’s safety, purity, and effectiveness. That’s why E&L testing is not just a recommendation—it’s a regulatory must.
Besides meeting legal standards, this testing shows your dedication to product safety and boosts confidence among healthcare providers. At ResolveMass, we strictly follow globally recognized guidelines such as USP <1663>/<1664> and ISO standards.
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Which Products Need E&L Testing?
Any medical or pharmaceutical product that touches packaging or delivery systems may require E&L testing. These include:
- Nasal sprays and inhalers
- Injectable drugs (ampoules, vials, prefilled syringes)
- Implantable devices
- IV tubing and reservoirs
- Plastic packaging for pharmaceuticals
Each product category comes with unique risks. That’s why ResolveMass offers testing strategies based on how your product is used and how long it’s in contact with its container.
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Extractables vs. Leachables – A Key Distinction
While both extractables and leachables are unwanted substances, they differ in how and when they’re identified. Extractables appear during stress testing with harsh chemicals, while leachables are found under normal use.
Leachables are usually more concerning since they reflect real-world use. Understanding the difference helps manufacturers focus on the risks that matter most, especially during toxicology and risk assessment stages.
Both are tested to assess chemical safety risk.
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What Guidelines Apply to E&L Testing?
When performing E&L testing, it’s crucial to follow the right industry rules. At ResolveMass Laboratories, we work within these globally accepted standards:
- USP <1663> and USP <1664>
- ICH Q3D (elemental impurities)
- ISO 10993 (medical devices)
- FDA and EMA guidance documents
We provide full documentation and detailed reports you can directly use in your FDA or EU submissions. Every method is validated for accuracy and reproducibility.
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When Should You Conduct E&L Testing?
The best time to start E&L testing is early in the product development cycle. Ideal stages include:
- Choosing materials and packaging
- Before starting preclinical or clinical trials
- During stability testing
- Before filing for regulatory approval
You should also repeat the testing if you change the formulation or container. Starting early saves time and avoids delays later in the approval process.
Common Testing Methods in E&L Analysis
We use top-tier scientific tools to detect both organic and inorganic extractables and leachables. These include:
- GC-MS for volatile compounds
- LC-MS for semi-volatile and non-volatile compounds
- ICP-MS for metals and elemental analysis
- FTIR, UV, TOC, and NMR for broader profiling
Every method we use is tailored to your product’s unique needs. That means better results and smoother approvals.
How Much Does E&L Testing Cost?
E&L testing costs can vary depending on your product and the complexity of the test. Factors include:
- Type of drug (inhalable, injectable, etc.)
- Number of materials involved
- Depth of toxicology evaluation required
At ResolveMass, we believe in clear pricing. We offer custom packages with no hidden charges—just honest value for your investment.
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Choosing the Right Lab for E&L Testing
Picking a lab for E&L testing is an important decision. You should consider:
- Regulatory experience and audit success
- Testing capabilities and instruments
- Track record with similar products
- Transparent communication and reporting
ResolveMass has completed over 500 successful E&L studies with a perfect regulatory approval rate. From planning to submission, we’re with you at every step.
Why ResolveMass Laboratories Is the Right Partner
At ResolveMass Laboratories, we bring a deep understanding of extractables and leachables along with unmatched customer support. Here’s why clients choose us:
- Long history in E&L testing
- Compliance with all global regulations
- Fast turnaround and secure data handling
- Friendly, expert project managers
- Tailored testing based on product risk
We’re more than a service provider—we’re your partner in delivering safe, high-quality healthcare solutions.
Most Asked FAQs on E&L Testing
Yes, E&L testing is mandatory or highly recommended for any product that comes in contact with its container or delivery system. Regulatory agencies like the FDA and EMA expect this data during submissions. Without proper E&L testing, your product could face delays or rejection.
Common extractables and leachables include plasticizers like DEHP, antioxidants, slip agents, monomers, and heavy metals. These substances can leach from plastic or rubber components into the drug product. Identifying them early is key to avoiding health risks.
Not all leachables are automatically harmful, but they must be evaluated through toxicological risk assessments. Experts look at safety thresholds such as TTC (Threshold of Toxicological Concern) and PDE (Permitted Daily Exposure) to determine potential impact on patients.
Yes, poor-quality or incomplete E&L data is one of the main causes of regulatory delays. Agencies may request retesting or clarification, which can slow down product approval. Working with a trusted lab like ResolveMass ensures your data is submission-ready.
No, E&L testing and stability testing serve different purposes. Stability testing checks how long a product remains effective over time, while E&L testing focuses on identifying chemicals that migrate from packaging materials. Both are essential for safety.
You’ll receive a full analytical and toxicological report, formatted to meet regulatory submission requirements such as IND, NDA, ANDA, and 510(k). The report includes detailed results, risk assessments, and method validation summaries tailored to your product.
Simulation testing uses harsh solvents to extract potential compounds under extreme conditions, mimicking worst-case scenarios. Real-use testing, on the other hand, evaluates chemical migration under normal storage and usage conditions. Both methods provide essential insights.
Conclusion: Trust ResolveMass for Your E&L Testing Needs
As you can see, the world of Extractables and Leachables Testing is complex—but it’s essential. This blog answered the top E&L Testing FAQs to help you understand the science, regulatory landscape, and importance of choosing the right partner. ResolveMass Laboratories Inc. combines cutting-edge technology with unmatched expertise to guide you every step of the way.
For questions, quotes, or custom consultation, please reach out.
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